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ClinicalTrials.gov Identifier: NCT01025609

Recruitment Status
:
Completed

First Posted
: December 3, 2009

Last Update Posted
: July 29, 2015

Sponsor:

Carolinas Healthcare System

Collaborator:

University of Minnesota - Clinical and Translational Science Institute

This study will look at dietary patterns in individuals with chronic spinal cord injuries and the relationship between these dietary patterns and cardiovascular disease risk factors. The study is a supplement to the Coronary Artery Risk Development in Young Adults (CARDIA) study. The dietary history from CARDIA will be used. The investigators' primary hypothesis is the following: Greater whole-grain and dietary fiber intake will be favorably associated with adiposity (BMI and WC) and metabolic CVD risk factors (fasting glucose, fasting insulin, HOMA-IR, diabetes, hsCRP, TC, HDL-C, triglycerides, TC/HDL-C ratio, non-HDL-C, and systolic and diastolic blood-pressure) among a sample of individuals with SCI aged 38-50 who have been injured >1 year.

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Ages Eligible for Study:

38 Years to 55 Years (Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Sampling Method:

Non-Probability Sample

Study Population

100 individuals with chronic spinal cord injuries

Criteria

Inclusion Criteria

Male or female, black or white with SCI due to a nonvascular insult that caused an acute spinal cord injury (i.e. traumatic injury, transverse myelitis without a diagnosis of multiple sclerosis, surgical complication, or benign neoplasm) at least 1 year prior to enrollment including ASIA A,B,C

Age at time of enrollment: > 38 years and <55 years (i.e., on or after 38th birthday and before 55th birthday)

Voluntary, informed consent of participant

Participant willing to comply with the testing protocols and questionnaires

Communication and comprehension sufficient for compliance with all testing procedures and measures Exclusion Criteria

SCI of a vascular or malignant etiology

Pregnancy, end-stage renal disease, treatment for cancer except for non-melanoma skin cancer in the past five years